Apparatus for capturing objects beyond an operative site utilizing a capture device delivered on a medical guide wire

ABSTRACT

An apparatus for removing a solid object from a body canal or vessel includes a coil of wire configured to slidably receive a guide wire and a sack having a mouth and a closed bottom opposite the sack. A resilient frame is connected between the coil of wire and the sack for biasing the mouth of the sack open around the coil of wire. The resilient frame is positionable between a collapsed state where the mouth of the sack is closed against the bias of the resilient frame and a deployed state where the mouth of the sack is biased open by the resilient frame.

BACKGROUND

1. Field of the Invention

The present invention is directed to capturing objects beyond anoperative site in any of a variety of medical procedures employed totreat any number of medical conditions in human and/or animal patients.

2. Description of the Prior Art

In many medical procedures, objects are dislodged or otherwise freed bythe surgeon during the surgical procedure, and it is useful and/ornecessary to capture the dislodged and/or otherwise freed object.

Although minimally invasive interventional medical therapies in general,and minimally invasive endovascular therapy in particular, are medicalprocedures where objects may be dislodged or otherwise freed during theprocedure, each has enjoyed unprecedented expansion to treat patientsbecause of the numerous medical benefits associated with not having toenter the body through more invasive surgical techniques. These benefitsinclude, but are not limited to, less trauma and/or scarring forpatients, less time to heal, less risk of infection and decreasedhospital stays, to name but a few.

More particularly, minimally invasive endovascular therapy is often usedto treat diseased vessels, e.g., arteries and veins. With such therapy,small instruments are inserted into the vessels through a puncture oraccess opening made in one of the vessels at an entry site and areadvanced through the circulatory system to an operative site where thevessel has become diseased, and the instruments are used to repair thediseased or operative site.

Typically, the goal of such therapy is to dilate full or partialblockages of the diseased vessel. Such blockages may have developed overtime or may have developed quickly, as for example, in response to aninjury. One common source of such blockage is thromboemboli which hasformed in the vessel. Thrombus is an aggregation of platelets, fibrin,clotting factors and cellular components of blood that spontaneouslyform and attach on the interior wall of a vein or artery, andthromboemboli are emboli of thrombus which operate to partially orcompletely occlude the interior or lumen of the blood or other vessel.

Techniques to open and/or maintain the dilation of the partially orcompletely occluded lumen of blood or other vessels include positioninga balloon across an obstruction or partially occluded section of thevessel, inflating the balloon to compress the build up (balloonangioplasty) and/or temporarily or permanently inserting a tube-likesupport within the vessels to keep the vessel open (stenting).

Minimally invasive endovascular therapy has the significant advantagethat it is less invasive than traditional surgical techniques and causesless trauma to the patient. However, this therapy is complicated by thefact that it can undesirably dislodge or free particles/objects duringthe procedure as discussed above, and in that the tools or instrumentsand workspace, e.g., the interior of the vessels of the body, are insome cases extremely small and close, and reaching the operative sitewith the tools is very difficult in some instances due to theconsiderable branching of the circulatory system that may occur betweenthe entry site into the blood vessel and the operative site. Thistherapy is further complicated by the fact that the entry site is oftenfar from the operative site, as for example, where the entry site is inthe thigh at the femoral artery and the operative site is located in theneck at the carotid artery. Even when the surgeon's instruments havebeen properly advanced to the operative site, manipulating the tools toperform their respective functions at the operative site is oftendifficult for the surgeon due to many factors including the closequarters at the operative site and the distance between the entry siteand the operative site.

One method and apparatus commonly used by surgeons to ensure the toolsreach the operative site is to first thread a simple guide wire to orbeyond the operative site. Thereafter, various tools are threaded overthe guide wire by the surgeon to reach the operative site. It is animportant aspect of such guide wires that they must be easy tomanipulate through the vessels, including in certain cases, throughlesions or areas of blockage in the vessel by the surgeon. In additionto exhibiting sufficient resiliency so as to be pushable in the vessel,the guide wire must exhibit sufficient flexibility and maneuverabilityto enable the surgeon to traverse the many twists and turns of thecirculatory (or other) system to reach the operative site.

An aspect of the ability for a surgeon to manipulate the guide wirethrough the circulatory or other system is the guide wire's“torquability”. As defined herein, the term “torquability” means that asthe surgeon rotates the proximal region of the guide wire that extendsoutside of the patient's body during the advancement of the guide wirethrough the patient's blood or other vessels to the operative site, theamount of rotation at the proximal region of the guide wire istransmitted to the distal end of the guide wire being inserted andadvanced through the patient's blood or other vessels to the operativesite. A lack of correlation between rotation at the proximal region ofthe guide wire and rotation at the distal end of the guide wire isreferred to as reduced torquability and is undesirable. A high degree ofcorrelation is referred to as a high degree of torquability and isdesirable. As may be appreciated, it is most desirable for the guidewire to have an exact correlation or high torquability between therotation applied proximally at the proximal region of the guide wire andthe rotation developed distally in the guide wire, so that the surgeoncan carefully control and direct the medical guide wire. With knowndevices, there is considerable difference between the amount of rotationapplied at the proximal region of the guide wire and the amount ofrotation developed at the distal end of the guide wire, making it verydifficult for surgeons to maneuver the distal end of the guide wire.

Even where the guide wire exhibits the desired torquabilitycharacteristics, and the tools have been properly threaded to theoperative site and have been properly manipulated to perform theirrespective functions at the operative site, there remains the problemnoted above, namely, that the process of dilating the occlusion and/orinserting the stent may dislodge or free small particles or objects,also known, among other things, as clots, fragments, plaque, emboli,thromboemboli, etc. More particularly, with respect to endovasculartherapy, the term “embolic event” has come to be used to describecomplications where thrombus or plaque is shed inadvertently from alesion to migrate to smaller vessels beyond the operative site to createa full or partial occlusion of the lumen of the vessel or vessels. Thisis most undesirable and can lead to many complications. Complicationsdepend upon the site in the body where such emboli lodge downstream ofthe operative site, but may include stroke, myocardial infarction,kidney failure, limb loss or even death. With increasing vigor, surgeonshave expressed the need to reduce the likelihood of such complicationsso that protection against embolic events will become a standardcomponent of endovascular therapy.

Devices have been made in the art to capture objects, including emboli,downstream of an operative site in medical procedures, includingendovascular therapy. Such devices generally employ a capture device,such as a bag or filter, which has a collapsed state and an expanded ordeployed state. Typically, the capture device is maintained in itscollapsed state within sheathing and is inserted into the blood or othervessel and is threaded beyond the operative site. It is then ejectedfrom the sheathing whereupon it expands to its deployed state to capturethe objects dislodged or otherwise freed during the medical procedure.

One device for removing clot or filtering particles from blood isdescribed in U.S. Pat. No. 4,723,549 to Wholey et al., which discloses adevice for dilating occluded blood vessels. This device includes acollapsible filter device positioned between a dilating balloon and thedistal end of the catheter. The filter comprises a plurality ofresilient ribs secured to the catheter that extend axially toward thedilating balloon. Filter material is secured to the ribs. The filterdeploys as a balloon is inflated to form a cup-shaped trap. An importantlimitation of the Wholey et al. device appears to be that the filterdoes not seal around the interior vessel wall. Thus, particles sought tobe trapped in the filter can instead undesirably pass between the filterand the vessel wall and flow downstream in the circulatory system toproduce a blockage. Another limitation is that the device also presentsa large profile during positioning. Yet another limitation appears to bethat the device is difficult to construct.

U.S. Pat. No. 4,873,978 to Ginsburg discloses a vascular catheter thatincludes a strainer device at its distal end. The device is insertedinto a vessel downstream from the treatment site and advanced to aproximal downstream location. The filter is contained in a sheath whenclosed. When pushed from the sheath, the filter deploys such that itsmouth spans the lumen of the vessel. Deployment is by expansion ofresilient tines to which the strainer material is attached. Again,however, it appears that the filter does not seal around the interiorvessel wall, thus undesirably allowing particles to bypass the filter bypassing between the filter and the vessel wall. The position of themouth relative to the sheath is also clinically limiting for theGinsburg device.

U.S. Pat. No. 5,695,519 to Summers et al. discloses a removableintravascular filter on a hollow guide wire for entrapping and retainingemboli. The filter is deployable by manipulation of an actuating wirethat extends from the filter into and through the hollow tube and outthe proximal end. One limitation with the Summers et al. device appearsto be that its filter material is not fully constrained. Therefore,during positioning within a vessel, as the device is positioned throughand past a clot, the filter material can snag clot material undesirablycreating freely floating emboli. It is unclear if the actuating wire canclose the filter, and it appears in any event that it will exert a pullforce on the rim of the filter that could tear the wire from the rim.Another limitation appears to be that the device application is limitedby the diameter of the tube needed to contain the actuating wire.

U.S. Pat. No. 5,814,064 to Daniel et al. discloses an emboli capturedevice on a guide wire. The filter material is coupled to a distalportion of the guide wire and is expanded across the lumen of a vesselby a fluid activated expandable member in communication with a lumenrunning the length of the guide wire. One limitation of the deviceappears to be that during positioning, as the device is passed throughand beyond the clot, filter material may interact with the clot so as toundesirably dislodge material and produce emboli. It is further believedthat the device may also be difficult to manufacture. Another limitationis that it is difficult to determine the amount of fluid needed toexpand the member. A lack of control can rupture and tear the smallervessels. Thus, the Daniel et al. device would appear to be morecompatible with use in the larger vessels only.

PCT Publication No. WO 98/33443 discloses a removable vascular filterwherein the filter material is fixed to cables or spines mounted to acentral guide wire. A movable core or fibers inside the guide wire canbe utilized to transition the cables or spines from approximatelyparallel the guide wire to approximately perpendicular the guide wire. Alimitation of this device appears to be that the filter does not sealaround the interior vessel wall. Thus, particles, e.g., emboli-formingmaterials, can undesirably bypass the filter by passing between thefilter and the vessel wall. Another limitation appears to be that thisumbrella-type device is shallow when deployed so that, as it is beingclosed for removal, the particles it was able to ensnare could escape.Yet another limitation is that the frame is such that the introductionprofile presents a risk of generating emboli as the device is passedthrough and beyond the clot, occlusion or stenosis.

U.S. Pat. No. 5,769,816 to Barbut et al. discloses a device forfiltering blood within a blood vessel. The device is delivered through acannula and consists generally of a cone-shaped mesh with apex attachedto a central support and open edge attached to an inflation seal thatcan be deflated or inflated. The seal is deflated during delivery andwhen delivery is complete, it is inflated to seal the filter around thelumen of the vessel. Limitations of this device include that it iscomplex to manufacture. Inflation and deflation of the seal addsadditional operative steps thus prolonging the operation-and introducingthe issue again of control, e.g., of how much to inflate to obtain aseal without causing damage to the vessel or other material. While thedevice may be suitable for large vessels, such as the aorta, is would bemost difficult to scale for smaller vessels, such as the carotid or thecoronary arteries.

U.S. Pat. No. 5,549,626 to Miller et al. discloses a coaxial filterdevice for removing particles from arteries and veins consisting of anouter catheter that can be inserted into a blood vessel and an innercatheter with a filter at its distal end. The filter is a radiallyexpandable receptacle made of an elastic mesh structure of spring wiresor plastic monofilaments. When pushed from the distal end of thecatheter, the filter deploys across the vessel lumen. A syringe attachedto the proximal end of the inner catheter aspirates particles entrappedin the filter. One limitation of this device appears to be that it ispossible that some particles will remain in the filter after aspirationsuch that, when the filter is retracted into the outer catheter,particles not aspirated are undesirably released into the circulatorysystem.

U.S. Pat. No. 6,027,520 to Tsugita et al. discloses a method and systemfor embolic protection consisting of a filter on a guide wire coupledwith a separate stent catheter deployed over the guide wire. Onelimitation of the Tsugita et al. device is that the many filter designssummarized in the patent generally lack a controllable, conformablecircumferential support in the mouth of the filters to ensure they sealaround the inside of a blood vessel. Without such a seal, it is againpossible for particulate material to evade the filter by undesirablypassing between the filter and the vessel wall, whereupon theparticulate material may flow downstream of the operative or other siteto produce full or partial blockage of the vessels. Many of the Tsugitaet al. filter expansion devices utilize multiple struts to open thefilter. These are not desirable as they increase the profile of thedevice when crossing a lesion, in turn, reducing the range of clinicalcases on which they can be used. Further, such designs add stiffness tothe region of the undeployed filter which can impede the surgeon'sability to direct the guide wire through the complex twists and turns ofthe circulatory system to the operative site, e.g., making it difficultto direct the device into a branching vessel. Also, the Tsugita et al.design is burdened by its use of a long deployment sheath to hold thefilter in a collapsed state and direct it to the operative site. TheTsugita et al. sheath extends from a hemostatic seal at the site ofentry into the blood or other vessel to the operative site (see column7, lines 56–58. and also column 8, lines 19–30 of the Tsugita et al.patent). This long sheath, necessary in the Tsugita et al. design,significantly impairs the ability to direct the guide wire through thecirculatory system to the operative site. Not only is such a sheath animpairment to directing the guide wire around the twists and turns ofthe circulatory system, but such a sheath also “loads” the guide wire,which operates to significantly reduce the Tsugita et al. system'storquability, greatly reducing the ability of the surgeon to control theguide wire and guide it through tight lesions.

At column 7, lines 28–32, Tsugita et al. states that its stent maycomprise a tube, sheet, wire, mesh or spring, and goes on to state thatsuch a stent can cover the plaque and substantially permanently trap itbetween the stent and the wall of the vessel. (see column 9, lines 55–58of the Tsugita et al. patent) However, this is not accurate, anddepending upon the type of stent, not only will it not trap such plaque,but plaque can reform through the interstices of the mesh whereupon thevessel can again become fully or partially occluded.

These shortcomings are present whether the stent is mechanicallyexpandable or self expanding. Relative to mechanically expandablestents, they are delivered with a stent catheter. See U.S. Pat. Nos.5,507,768; 5,158,548 and 5,242,399 to Lau et al. incorporated herein byreference. The catheter has an inflatable balloon at or near the distalend on which the stent is mounted. An inflation lumen runs the length ofthe catheter to the balloon. Generally, the stent is a tubular meshsleeve. See U.S. Pat. No. 4,733,665 to Palmaz incorporated herein byreference. A self-expanding stent is typically made of Nitinol. It iscompressed within a catheter until deployment. It is pushed from thecatheter to deploy it. Both types of stents tend to create embolicparticles. Also, both allow stenotic material to build up through theinterstices of the wire mesh that could again occlude the artery.

Permanent filters for the vena cava are well-established clinicaldevices. These open filters capture large emboli passing from a surgicalsite to the lungs. U.S. Pat. No. 3,952,747 to Kimmell, Jr. et al.discloses the Kimray-Greenfield filter. It is a permanent filtertypically placed in the vena cava and consists of a plurality ofconvergent legs in a generally conical array Each leg has a hook at itsend to impale the interior wall of the vena cava. U.S. Pat. Nos. thatare joined at their convergent ends to an apical hub. U.S. Pat. No.4,425,908 to Simon; U.S. Pat. No. 4,688,553 to Metals; and U.S. Pat. No.4,727,873 to Mobin-Uddin are also illustrative of such devices.

U.S. Pat. Nos. 5,669,933 and 5,836,968 to Simon et al. are illustrativeof removable blood clot filters suitable for the venous system,specifically the vena cava.

However, the presently available capture devices all suffer from thelimitation that they are not easily manipulated in the patient's body.They usually include tube-like sheathing material which extends allalong the length of the guide wire used to insert the capture deviceinto the vessel, generally extending from the entry site into the body,also known as an access port or access opening to the operative site,which sheathing operates to contain the capture device until its desireddeployment in the vessel beyond the operative site. Such sheathingmaterial operates to reduce torquability of the guide wire used toinsert the capture device and operates to significantly reduce theflexibility of wire within the circulatory or other system as notedabove. Removal without causing excessive movement of the deployed filteris also a problem. As the sheath is pulled from the access port duringremoval, the surgeon must continually reposition his hand to hold thewire used to insert the capture device, that is, as the sheath is pulledthrough the access port, the surgeon must release the wire and thenre-grasp further down from the access port. As the surgeon's hand graspsthe wire further from the access port, the more difficult it becomes tosteady the guide wire as the sheath is withdrawn. As such, the capturedevice may move back and forth, and as it is generally at this point inits expanded state, the constant rubbing of the wall of the blood orother vessel or canal by the capturing device may irritate or injure thewall of the blood or other vessel or canal. Another complication is thatseveral capture devices include bulky or complex deployment mechanisms,and further, when deployed, fail to fully seal around the interior ofthe vessel or other wall or fail to prevent unwanted release of capturedparticles, fragments, objects, emboli, etc., whereupon such particles,fragments, objects, emboli, etc. can undesirably escape and travelbeyond the capture device.

Thus, there is a need in the art for a capture device and methods ofconstructing and using such device, which is easily threaded through thevessels or canals of humans and/or animals to reach an operative site,which exhibits excellent torquability, flexibility and maneuverability,which is easily removable along with its captured objects once themedical procedure has been completed without injuring or irritating thewall of the vessel or canal, and which forms a seal with the wall of thevessel or canal or otherwise prevents the undesirable escape ofparticles, fragments, objects, emboli, etc. beyond the capture deviceduring surgery. There also is a need in the art for a system ofassociating surgical tools with such a capture device to provideprotection downstream of an operative site for the capture of objectsdislodged and/or freed during the medical procedure.

SUMMARY OF THE INVENTION

Accordingly, I have invented an apparatus for removing a solid objectfrom a body canal or vessel. The apparatus includes a coil of wireconfigured to slidably receive a guide wire and a sack having a mouthand a closed bottom opposite the mouth. A resilient frame is connectedbetween the coil of wire and the sack for biasing the mouth of the sackopened around the coil of wire. The resilient frame is positionablebetween a collapsed state where the mouth of the sack is closed againstthe bias of the resilient frame and a deployed state where the mouth ofthe sack is biased open by the resilient frame.

The apparatus can include a containment collar configured to slidablyreceive the guide wire therethrough and to receive the resilient frametherein. A pull wire can be connected to the containment collar so thatin response to relative movement between the guide wire and the pullwire, the resilient frame is positionable between the collapsed stateinside the containment collar and the deployed state outside thecontainment collar. The guide wire can include a proximal stop and adistal stop in spaced relation on the guide wire. The coil of wire canbe received on the guide wire between the proximal stop and the distalstop and each stop can be configured to avoid the slidable passage ofthe coil of wire thereby.

Preferably, the closed bottom of the sack is connected to the coil ofwire adjacent one end thereof, the resilient frame is connected to thecoil of wire adjacent the end thereof opposite the closed bottom of thesack, and the mouth of the sack is connected to the wire frame betweenthe ends of the coil of wire.

The apparatus can include a deployment catheter having a lumenconfigured to slidably receive the guide wire. The guide wire caninclude a distal stop configured to avoid the slidable passage of thecoil of wire thereby. The deployment catheter can have an end configuredto abut an end of the coil of wire when the coil of wire is received onthe guide wire between the deployment catheter and the distal stop.

Alternatively, the apparatus can include a deployment catheter having alumen configured to slidably receive the guide wire and at least part ofthe resilient frame therein so that in response to relative movementbetween the guide wire and the deployment catheter, the resilient frameis positionable between the collapsed state at least partially insidethe deployment catheter and the deployed state outside the deploymentcatheter.

Preferably the coil of wire is a helically wound spring that is firmaxially and pliable laterally.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A–1D are side views of a device for capturing objects beyond anoperative site utilizing a capture device in accordance with the presentinvention mounted on a guide wire.

FIG. 2 is a perspective view of a wire frame of the capture device ofFIGS. 1A–1D, with the wire frame in its deployed state.

FIG. 3 is a side view of the wire frame in FIG. 2 in its collapsedstate.

FIG. 4 is a side view of the collapsed wire frame shown in FIG. 3received within a containment collar in accordance with the presentinvention.

FIG. 5 is a side view of the collapsed wire frame and containment collarof FIG. 4 with a filter or sack connected to the wire frame andretracted partially into the containment collar.

FIG. 6 is a partial cross-sectional side view of a partially deployedwire frame and filter of FIG. 5 with particles captured in the filter.

FIG. 7A is a side view showing coiling of a pull wire around the guidewire.

FIG. 7B is a partial cross-sectional side view of the present inventionshowing an alternate embodiment for affixing the pull wire to thecontainment collar.

FIG. 8 is a perspective view of another embodiment of the presentinvention for affixing the pull wire about the guide wire and furtherillustrating the use of a guide catheter.

FIGS. 9A and 9B are different side views of another embodiment of thepresent invention showing a wire frame and filter slidably received onthe guide wire.

FIG. 10A is a side view of a retrieval catheter assembly received on aguide wire in its undeployed state.

FIG. 10B is a side view of the retrieval catheter assembly shown in FIG.10A in a partially deployed state where a wire frame attached to theguide wire is partially retracted into a sheath of the retrievalcatheter assembly.

FIG. 10C is a section taken along lines XC—XC in FIG. 10A.

FIGS. 11A and 11B are perspective and side views, respectively, ofanother embodiment of a capture device of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention relates generally to a method and apparatus forcapturing objects beyond an operative site in any of a variety ofmedical procedures employed to treat any number of medical conditions inhuman and/or animal patients.

More particularly, the apparatus of the present invention includes inone embodiment, a novel object capture device integrally incorporated aspart of a medical guide wire or otherwise mounted on or affixed to amedical guide wire, which medical guide wire is inserted into the humanor animal patient and is threaded or otherwise advanced in the bodythrough one or more of the body's canals or vessels to and/or beyond anoperative site. As disclosed in more detail below, the novel objectcapture device includes a frame having a sack or filter attachedthereto, and the object capture device operates to capture objects,e.g., emboli, beyond the operative site.

The present invention includes in yet another embodiment, a system forthe endovascular treatment of blood or other vessels which includes thecombination of the capture device on a medical guide wire with otherdevices, e.g., endovascular devices, such as dilation balloon systems,stent deployment systems, mechanical and/or laser thrombectomy devicesand combinations thereof, that track over the guide wire, for use inmedical procedures to treat humans and/or animals.

The methods of the present invention include methods of constructing theapparatus and system of the present invention, and methods of using thenovel object capture device of the present invention to treat medicalconditions in human and/or animal patients.

Referring now to FIGS. 1A–1D, an “on-the-wire” endovascular device 2 forcapturing and removing objects, particles and/or other solid orsemi-solid matter in blood or other vessels, organs, canals and/or bodycavities of a patient according to the teachings of the presentinvention is shown. The following description of endovascular device 2will also illustrate one or more embodiments of a method for insertionand removal of the device in a blood or other vessel in the body.

FIGS. 1A and 1B illustrate endovascular device 2 in its collapsed stateor structure where an object capturing filter which includes a resilientframe, preferably a resilient wire frame 8, and a sack 12 affixed towire frame 8, described in more detail below, is contained within acontainment collar 32.

More particularly, starting at the right side of endovascular device 2as viewed from the orientation of an observer viewing FIG. 1A,endovascular device 2 includes an elongated guide wire 4 received in andthrough containment collar 32. The length of guide wire 4 is notlimiting to the present invention, and may be of any length necessary toextend from an entry site or access opening 41 into a body canal orvessel to the operative site. Break lines 5 shown in FIG. 1A illustratethat the length of endovascular device 2 may be modified as necessaryfor a given surgical application.

As shown in FIG. 1A, containment collar 32 can be constructed of anopaque material. However, as shown in FIGS. 1B–1D, containment collar 32can also be constructed of a transparent material. Suitable materialsfor the construction of containment collar 32 are described below.

A pliable tip 22 is preferably connected to or integrally formed as partof the distal end of guide wire 4. Pliable tip 22 is preferably formedfrom a biocompatible material having a spring memory. Suitable materialsfor the construction of pliable tip 22 include platinum wire.Preferably, the biocompatible material forming pliable tip 22 is woundinto a coil with one end of pliable tip 22 attached to the distal end ofguide wire 4 and with the other end of pliable tip 22 extending awayfrom guide wire 4. Pliable tip 22 facilitates the advancement of thedistal end of guide wire 4 and containment collar 32 through the varioustwists and turns of a patient's circulatory or other system.

In FIG. 1B; wire frame 8 is contained in a collapsed state or structurewithin containment collar 32. In contrast, in FIG. 1C, wire frame 8 isillustrated deployed outside of containment collar 32 in an expanded ordeployed state or structure.

Preferably, wire frame 8 is connected to guide wire 4 via a junction 10.This connection may be made by any means, such as soldering, brazing andthe like, but may also include wire frame 8 and guide wire 4 beingintegrally formed together as one unit.

FIGS. 1B–1D show one non-limiting embodiment of wire frame 8 that may beemployed in the present invention. Wire frame 8, however, may includeany known frame configuration which can be in a collapsed state insidecontainment collar 32 during insertion into the patient and its travelto or beyond the operative site, which can be transitioned into adeployed state within the patient and which can be returned to a fullyor partially collapsed state for removal. Containment collar 32 is notlimited to use with wire frame 8, but can be used with any deployabledevice, that transitions from a collapsed state inside containmentcollar 32 to a deployed state in a body vessel, canal, organ or openarea of any kind in a patient. Preferably, containment collar 32 isgenerally cylindrical. However, containment collar 32 can have anyshape, e.g., square, rectangular, elliptical, trapezoidal, that enableswire frame 8 to transition from a collapsed state to a deployed state.

Where containment collar 32 is used with wire frame 8 having sack 12thereon, preferably, wire frame 8 must be able to urge a mouth 14 ofsack 12 against an inside wall of the body canal or vessel in which sack12 is positioned in its deployed state so that objects do not passbetween mouth 14 of sack 12 and the wall of the patient's body canal orvessel. Mouth 14 of sack 12 is connected to wire frame 8, such as, forexample, by gluing or melting mouth 14 of sack 12 to wire frame 8.

In the embodiment shown in FIG. 1C, sack 12 has its mouth 14 connectedto an end of wire frame 8, and sack 12 has a closed end or bottom 16opposite mouth 14. Sack 12 has a generally bag-like shape, preferably aconical shape when deployed. However, sack 12 can have any shape capableof ensnaring objects in the vessel or canal of a patient, e.g., ahemispherical shape.

Guide wire 4 projects through mouth 14 and bottom 16 of sack 12 andterminates at a distal end a distance 18 from bottom 16 of sack 12.Preferably, guide wire 4 extends through and is connected to an apex 20of bottom 16.

Containment collar 32 has a short generally tubular shape with a lumen36 of sufficient diameter to enable guide wire 4 to pass therethroughand to contain wire frame 8 and sack 12 in closed configuration withinlumen 36 of containment collar 32. The length of containment collar 32is preferably no greater than needed to contain wire frame 8 and sack 12therein in a collapsed state during insertion of endovascular device 2into the patient. Rather, as shown in FIG. 5, containment collar 32 maybe shorter still to leave apex 20 exposed when wire frame 8 and sack 12are in their closed configuration.

A pull wire 34 extends from containment collar 32 to a point external ofthe patient via the access opening 41 after placement of endovasculardevice 2 at or beyond the operative site. Pull wire 34 enablescontainment collar 32 to be pulled proximally, i.e., in the directionillustrated by an arrow 9 in FIG. 1A, while guide wire 4 remainsstationary or conversely to advance guide wire 4 distally, i.e., in thedirection of an arrow 3, while holding pull wire 34 stationary,whereupon containment collar 32 is pulled off of wire frame 8 or,conversely, wire frame 8 is ejected from containment collar 32 therebydeploying wire frame 8 to its deployed state shown in FIG. 1C. Theprecise length of pull wire 34 is not limited, as illustrated by thebreak lines 7, provided pull wire 34 extends from containment collar 32to a point external of the patient.

With reference to FIGS. 4 and 5, and with continuing reference to FIGS.1A–1D, pull wire 34 may be attached by any known means, such as gluing,brazing, welding, soldering, integral forming and the like. Preferably,however, containment collar 32 has a portion or area 33 of reducedinternal and external diameter. Portion 33 defines a lumen 37 that iscontinuous with lumen 36 of containment collar 32. Lumens 36 and 37 areof sufficient size to enable guide wire 4 to slide therethrough.Preferably, containment collar 32 is made of a material that shrinksupon application of heat, and portion 33 is formed by applying heatthereto and allowing it to shrink to the extent desired to form portion33 of reduced diameter. Such heat shrinkable materials are presentlyavailable for a wide variety of applications both within and not withinthe medical arts.

A tubular component 39 is inserted into portion 33 of containment collar32 prior to the application of heat to portion 33 described above. Heatis then applied to portion 33 thereby causing portion 33 to shrink aboutthe exterior circumference of tubular component 39. In this manner,tubular component 39 frictionally engages containment collar 32,particularly portion 33.

Tubular component 39 is associated with pull wire 34, and tubularcomponent 39 operates to connect pull wire 34 to containment collar 32via tubular component 39. Pull wire 34 may be connected to tubularcomponent 39 by any various means including, but not limited to,welding, brazing, soldering or integral forming. Preferably, however,tubular component 39 is formed by coiling pull wire 34 adjacent itsdistal end, as shown in FIG. 4. In this embodiment, tubular component 39has a lumen 40 which is continuous with lumen 36 of containment collar32 and is of sufficient diameter to permit guide wire 4 to be slidablyreceived in lumen 40 to permit relative movement between guide wire 4and containment collar 32 and tubular component 39. The axial length ofportion 33 needs only be sufficient to permit tubular component 39 to besufficiently grasped by containment collar 32 upon application of heatto portion 33 so as to enable endovascular device 2 to be delivered intoand removed from a patient without tubular component 39 separating fromcontainment collar 32, but it may be longer.

A length of approximately 12 centimeters for portion 33 ensures thattubular component 39 remains within and does not exit a distal end of alumen of a guide catheter 42 (shown in FIG. 1 a) common to endovascularprocedures when wire frame 8 and sack 12 are properly positioned pastthe lesion. In other words, when wire frame 8 and sack 12 are positionedpast a lesion, a length of at least 12 centimeters of portion 33 ensuresthat tubular component 39 is sufficiently spaced from wire frame 8 andsack 12 that tubular component 39 will remain within the confines ofguide catheter 42, as shown in FIG. 1A. Keeping tubular component 39within the confines of guide catheter 42 is desirable, as it is one lessitem that can contact the vessel walls and operate to undesirablydislodge particles, e.g., emboli. It is to be appreciated, however, thatit is not necessary to use endovascular device 2 with guide catheter 42,and that endovascular device 2 can be positioned in a body canal and/orvessel of a patient without utilizing guide catheter 42.

Containment collar 32 is an important element of the present invention.Unlike known continuous sheaths which, without interruption, extend froma point external of the patient through an access opening 41 and all theway to the operative site to contain an object capture device therein,containment collar 32 of the present invention does not, and is only ofsuch length as is necessary to contain wire frame 8 and sack 12 in acollapsed state. Importantly, containment collar 32 of the presentinvention does not present a significant anti-torque load along theentire length of guide wire 4 from its distal end at the operative siteto its point of access from the body, as do presently availablecontinuous sheaths. Therefore, unlike known sheaths, containment collar32 does not reduce the torquability of endovascular device 2 of thepresent invention as will occur with a continuous sheath which extendsfrom the distal end of guide wire 4 at the operative site to accessopening 41. This is particularly advantageous during insertion andpositioning of endovascular device 2 in a patient.

As noted above, pull wire 34 is of sufficient length to extend from aprocedural or surgical site in a vessel to and through access opening41. For most applications, the length of pull wire 34 is typically atleast 100 centimeters long, although any length may be employed asindicated by break lines 7 in FIGS. 1A–1C. Optionally, pull wire 34 mayhave a handle 38 positioned so as not to interfere with the vascularaccess site and to aid the surgeon's grasp of pull wire 34. Handle 38may be permanently or removably affixed to pull wire 34. Alternatively,a pin vice, clamp or similar device that would grasp pull wire 34 andaid the surgeon's grasp of pull wire 34 can be employed.

It is standard clinical practice to position guide wire 4 within guidecatheter 42 to direct other surgical instruments into the body alongguide wire 4 but within guide catheter 42. More specifically, pliabletip 22; containment collar 32 with wire frame 8 and at least part ofsack 12 received therein; tubular component 39 with portion 33 heatshrunk to tubular component 39; the section of guide wire 4 received intubular component 39 and containment collar 32; the portions of guidewire 4 to either end of containment collar 32; and the portion of pullwire 34 connected to tubular component 39 are inserted into a patientvia access opening 41.

Containment collar 32 is guided through the patient's body canal(s)and/or vessel(s) using pliable tip 22 in order to position containmentcollar 32 to a desired position at and/or adjacent, typically beyond,the operative site. The high degree of torquability resulting from theuse of containment collar 32 over any previously available deviceensures that the surgeon maintains excellent control over the threadingand guiding of endovascular device 2 through the twists and turns of thepatient's body canals and/or vessels that are present between accessopening 41 and the operative site.

When located at the desired position, pull wire 34 is then pulledproximally in the direction of an arrow 11, illustrated in FIG. 1A,while guide wire 4 is held or otherwise maintained in a stationaryposition. As pull wire 34 moves in the direction of arrow 11,containment collar 32 moves axial along guide wire 4 relative to sack 12and wire frame 8, whereupon containment collar 32 is retracted orwithdrawn from wire frame 8 and sack 12. This allows wire frame 8 toexpand to its deployed state, illustrated in FIG. 1C, whereupon wireframe 8 urges mouth 14 of sack 12 against the blood or other vesselwall, where sack 12 can capture objects dislodged at or near theoperative site during the operation. Containment collar 32 may beretracted over guide wire 4, completely removed from the patient's bodyand withdrawn from guide wire 4 after deployment.

During a procedure, such as, for example, angioplasty or stenting, otherover-the-wire or monorail devices may be introduced over guide wire 4.In its deployed state, sack 12 captures the particles dislodged duringthe procedure.

When the procedure is complete, a tubular retrieval catheter or recoverysheath 6 is advanced over guide wire 4 into the patient, as shown inFIG. 1D. The length of recovery sheath 6 is not limiting to theinvention as illustrated by the break lines 52, but recovery sheath 6must extend from outside the patient's body, where it may be manuallymanipulated to where sack 12 and wire frame 8 are positioned at thedesired position during the procedure. Advancement of recovery sheath 6in the direction of the arrow 56 causes recovery sheath 6 to advancedistally along guide wire 4 over wire frame 8 and, more particularly,each half frame 24 making up wire frame 8 as explained in more detailbelow, closing mouth 14 of sack 12, and capturing particles 58 receivedwithin sack 12. Sack 12 can be retracted partially or completely intorecovery sheath 6 and the assembly comprising recovery sheath 6, thecaptured wire frame 8, and sack 12 are withdrawn from the patient, alongwith particles 58 captured in sack 12.

In one embodiment of the invention, a prior art support guide wire maybe threaded to a location proximal to the desired location; guidecatheter 42 introduced over the support guide wire, the support guidewire removed; and endovascular device 2 of the present invention maythen be advanced to the desired location through guide catheter 42,where its wire frame 8 and sack 12 are deployed distally of guidecatheter 42 and used to capture objects, particles, etc., in the mannerdescribed above.

Containment collar 32 is preferably made from Teflon tubing, preferablyhaving a wall thickness less than 0.004 inches, however, containmentcollar 32 can be made from other flexible biocompatible materials, suchas polyethylene, nylon or polyimides, that permit relative axialmovement between guide wire 4 and containment collar 32. To promoterelative axial movement therebetween when containment collar 32 is madeof a material other than Teflon, the inside surface of containmentcollar 32 and/or guide wire 4 can be coated with a tough flexiblelubricious coating, such as Teflon or a hydrophilic film. Moreover, theinside surface of containment collar 32 and/or guide wire 4 can receivea biocompatible lubricant, such as silicon.

With reference to FIG. 2, and with continuing reference to FIGS. 1A–1D,in one embodiment of the present invention, wire frame 8 includes a pairof half frames 24 connected in mirror image relation to guide wire 4 viajunction 10. Each half frame 24 has a pair of control arms 26 connectedat their proximal ends to guide wire 4 via junction 10. Alternatively,control arms 26 may be integrally formed with the respective half frame24.

Junction 10 can include any known means of joinder, such as a crimp ofbiocompatible material; a solder joint of appropriate biocompatiblematerial; or a weld that connects half frames 24 to guide wire 4. Thedistal end of each half frame 24 has a partial loop 28 that extendsbetween control arms 26. Half frames 24 are preferably fully orpartially constructed of a shape-memory-effect alloy, such as Nitinol,in its super-elastic state, although the present invention is notlimited to half frames 24 comprised of Nitinol. The shape-memory-effectalloy enables each half frame 24 to be “trained” or formed so that in arelaxed undeformed state control arms 26 diverge between junction 10 andpartial loop 28, and partial loop 28 extends transverse, preferablyperpendicular, to the longitudinal axis of guide wire 4, with an insideradius of partial loop 28 facing guide wire 4 as illustrated in FIG. 2.Wire frame 8 and, more particularly, half frames 24 and control arms 26are preferably formed from solid Nitinol, tubular Nitinol or strandedNitinol.

In another embodiment (not shown), each half frame 24 includes anarcuate section connected to the distal end of each control arm 26. Thearcuate sections extend from their respective control arms 26 andterminate with their ends touching or in spaced relation forming a gaptherebetween. The arcuate sections can be formed by separating, as forexample, by cutting, each partial loop 28 intermediate control arms 26.The arcuate sections can be configured to form a partial or completeloop. In yet another embodiment, wire frame 8 can include a completeloop (not shown) connected to the distal ends of control arms 26. Again,the precise design of wire frame 8 is not limiting to the presentinvention and any frame design may be employed. Other frame designs, forexample, are described in U.S. Pat. Nos. 5,779,716; 5,910,154;5,911,734; and 6,027,520 which are incorporated herein by reference.

To enable wire frame 8 to be viewed more clearly under fluoroscopicvisualization inside a body canal or vessel, a wire or thread 30 madefrom a biocompatible radiopaque material(s) is wrapped around or bondedto one or more partial loops 28, one or more control arms 26 and/orwoven into the rim of mouth 14 of sack 12. For example, stranded Nitinolwith a central strand of radiopaque material or Nitinol tubing filledwith radiopaque material can be used to form partial loops 28 and/orcontrol arms 26 that can be viewed more clearly under fluoroscopicvisualization. Alternatively, partial loops 28 and/or control arms 26are coated with the biocompatible radiopaque material(s) or a coil ofradiopaque material can be wound around each partial loop 28 and/or eachcontrol arm 26. To enable pliable tip 22 to be viewed under fluoroscopicvisualization inside a body canal or vessel, at least the distal end ofpliable tip 22 may be made from or coated with the biocompatibleradiopaque material(s). Examples of biocompatible radiopaque material(s)include gold, tungsten and platinum or combinations thereof.

During insertion of deployed wire frame 8 into containment collar 32during manufacture and/or prior to insertion into a patient, pullingguide wire 4 proximally relative to containment collar 32 causes controlarms 26 and partial loops 28 to interact with the inside diameter anddistal end of containment collar 32 whereby control arms 26 and partialloops 28 deform and, more particularly, converge toward guide wire 4 asthey are received in containment collar 32. As shown in FIG. 3, withoutcontainment collar 32 for illustrative purposes, and in FIG. 4, withcontainment collar 32 present, and in FIG. 5, with both containmentcollar 32 and sack 12 present, when control arms 26 and partial loops 28of half frames 24 are received in containment collar 32, they arestressed within the elastic limits of the shape-memory-effect alloy toform elongated loops having axes positioned substantially parallel tothe longitudinal axis of guide wire 4. The super-elastic property of theshape-memory-effect alloy enables half frames 24 to return to therelaxed undeformed shape, shown in FIG. 2, when they are deployed fromcontainment collar 32 in the manner described above.

Sack 12 is formed of a biocompatible material having sufficient strengthto withstand forces associated with deployment in body canals or vesselsand forces associated with ensnaring/retaining particles, objects, etc.,within sack 12. The material may be either non-porous or porous, but ispreferably porous. Sack 12 made of non-porous material occludes flow inthe vessels. Sack 12 made of porous material allows flow of a fluid,e.g., blood, in the vessels, and permits particles of smaller diameterthan the pores of sack 12 to escape therethrough. Preferably, sack 12 isformed from a polymeric material, such as polyurethane, which is eitherporous or non-porous. Sack 12 can also be made radiopaque through theaddition thereto of barium sulfate or bismuth sulfate or threads ofradiopaque materials interwoven or otherwise associated with sack 12.Sack 12 can also be made of other biocompatible materials, such as wovenpolyester fabrics.

A rim of mouth 14 of sack 12 surrounds and is bonded to half frames 24to secure sack 12 to wire frame 8. Similarly, apex 20 of bottom 16 ofsack 12 is bonded to the projection of guide wire 4 therethrough tosecure sack 12 to guide wire 4. Chemicals and/or heat can be utilized tobond sack 12 to guide wire 4 and wire frame 8. Preferably, sack 12 isbonded between half frames 24 and guide wire 4 so that no gaps existbetween sack 12 and guide wire 4, and sack 12 and wire frame 8.

Sack 12 preferably has a conical shape as illustrated in FIG. 1C.However, sacks having more hemispherical shapes, as illustrated in FIGS.2, 6, 9, 10 and 11 of U.S. Pat. No. 5,779,716 may also be employed.Conical-shaped sacks have the advantage that as objects, particles, etc.fill bottom 16 of sack 12, sack 12 still permits flow of fluid, e.g.,blood, into and out of sack 12 proximal of the build up of particles,objects, etc. in sack 12, as illustrated in FIG. 6.

The size of the body canal and/or vessel, more particularly, thediameter of the lumen of the vessel in which endovascular device 2 ofthe present invention is to be deployed, establishes the dimensions ofmouth 14 of sack 12 when wire frame 8 is in its deployed state that canbe utilized to capture particles, objects, etc. Specifically, thedimensions of wire frame 8 in its deployed state are selected so thatmouth 14 of sack 12 is urged snugly with the intima of the vessel.Preferably, wire frame 8 is configured to be firm and pliable so thatinteraction between wire frame 8 and the intima of the vessel avoidstrauma to the vessel and yet provides a firm or snug opposition betweenmouth 14 of sack 12 and the intima of the vessel. In an exemplaryembodiment, control arms 26 and partial loops 28 of wire frame 8 havediameters between 0.003 to 0.010 inches (0.0076 cm to 0.025 cm), guidewire 4 has a diameter between 0.010 to 0.035 inches (0.025 cm to 0.088cm), and containment collar 32 has an outside diameter between 0.025 to0.130 inches (0.064 cm to 0.33 cm).

The lengths of pull wire 34 and guide wire 4 are selected based on theposition of access opening 41 for inserting endovascular device 2 in thelumen of the body canal and/or vessel relative to the position in thelumen of the solid material capable of producing movement of particles,as described above.

Endovascular device 2 can be used in several ways depending on its exactconfiguration and the area of the cardiovascular system involved. By wayof a specific non-limiting but illustrative example, interventional useof endovascular device 2 to capture emboli shed during a procedure, suchas angioplasty and stent placement, to treat a stenosis in the carotidartery of a human patient, will now be described with reference to FIGS.1A–1D, 5 and 6.

Starting with wire frame 8 and sack 12 received in containment collar 32and with at least pliable tip 22 extending from containment collar 32,endovascular device 2 is inserted percutaneously into the patientthrough guide catheter 42 previously inserted in access opening 41 inthe patient's femoral artery. Under fluoroscopic visualization, guidewire 4 is manipulated to advance pliable tip 22 and containment collar32 through guide catheter 42 in the patient's circulatory system untilreaching the carotid artery. Guide wire 4 is further advanced beyondguide catheter 42, guided by pliable tip 22 through the remainder of thecarotid artery to, across and beyond a stenosis in the internal carotidartery. Containment collar 32 is now positioned at a desired position inthe internal carotid artery so that, when deployed, wire frame 8 andsack 12 are downstream of the stenosis in the internal carotid artery tocapture and retain any dislodged emboli particles.

To deploy wire frame 8 and sack 12, a portion of guide wire 4 outsidethe patient's body is held steady and a portion of pull wire 34, orhandle 38, outside the patient's body is grasped and pulled in thedirection of arrow 11 so that containment collar 32 is retracted orwithdrawn from over wire frame 8 and sack 12, thereby enabling wireframe 8 to deploy and to hold mouth 14 of sack 12 snugly against thewall of the internal carotid artery.

Thereafter, containment collar 32 is pulled in the direction of arrow 11while guide wire 4 remains stationary until containment collar 32 isremoved completely from guide wire 4 and the patient, thereby enablingother over-the-wire or monorail devices or components used during theprocedure to be received on guide wire 4 and delivered through guidecatheter 42 to the stenosis. Other over-the-wire or monorail devicesinclude, but are not limited to, endovascular devices such as dilationballoon systems, stent deployment systems, mechanical and/or laserthrombectomy devices and combinations thereof that track over guide wire4 and are used to reduce the stenosis.

With regard to stent deployment systems, the stent may be either aself-expanding stent or a mechanically expandable stent. Stents areusually in the form of a tubular mesh sleeve. See, for example, U.S.Pat. No. 4,733,665 to Palmaz, incorporated herein by reference. Eithertype of stent is typically delivered via a stent catheter.

For the mechanically expandable stent, the stent catheter includes at ornear its distal end an inflatable balloon on which the stent is mounted.An inflation lumen runs the length of the stent catheter to the balloon.The stent catheter includes a guide lumen which runs the length of thestent catheter and which is configured to receive guide wire 4 therein.In use, the proximal end of guide wire 4 is inserted into the guidelumen of the stent catheter. Thereafter, the stent catheter is advancedon guide wire 4 until the inflatable balloon on which the stent ismounted is positioned at an appropriate point in the vessel, e.g.,wholly or partially across a stenosis. Thereafter, the balloon isexpanded via the inflation lumen causing the stent, in turn, to expandand in its expanded state to hold itself with a frictional fit againstthe walls of the vessel into which it has been inserted.

The self-expanding stent is typically made in whole or part from ashape-memory-effect alloy and is compressed within a delivery catheteruntil deployment. Pushing the stent from the delivery catheter deploysthe stent to an expanded state, much in the same manner as wire frame 8expands upon release from containment collar 32.

An unfortunate aspect of stents that are of the tubular mesh design isthat they tend to create particles, e.g., emboli, due to their open meshstructure. As they expand, embolic material is able to disperse throughthe mesh to the interior of the stent where the flow of blood or otherfluid undesirably washes particles of embolic material downstream in thecirculatory or other system. Further, even after successfulimplantation, the open mesh structure tends to permit stenotic materialto build up through the mesh that could again occlude the artery.Therefore, in a preferred embodiment of the present invention, where thesystem includes endovascular device 2 of the present invention, andwhere additional over-the-wire stent deployment systems are used as partof the system, the stent preferably includes a sheathing or coatingmaterial associated with the open mesh structure of the stent. Thismaterial may be on the outside of the stent, the inside lumen of thestent, or both. The stent may also be embedded within an envelope ofsuch material. Such material is biocompatible and operates to preventstenotic material from advancing from the walls of the vessel throughthe open mesh structure of the stent and into the circulatory or othersystem during implantation of the stent. Examples of suitable materialsfor encasing all or a portion of the stent include, but are not limitedto, Dacron, Gortex and combinations thereof.

After the stenosis has been reduced and the other over-the-wire ormonorail components are removed from guide wire 4, recovery sheath 6 ispositioned over guide wire 4 and advanced through guide catheter 42, ifguide catheter 42 has been permitted to remain in the patient up to thispoint toward, and beyond the operative site to contact wire frame 8 andsack 12. As the lumen of the carotid artery in this region has now beenexpanded, in this example, by the stent, recovery sheath 6 may safelyhave a larger diameter than containment collar 32 without the danger ofdislodging stenotic material. Further, recovery sheath 6 may be moreeasily advanced through the operative site now that the lumen has beenexpanded. Further advancement of recovery sheath 6 in the direction ofarrow 56 and/or pulling of guide wire 4 in the direction of arrow 11,causes all or a portion of wire frame 8 and all or a portion of sack 12to be retracted into recovery sheath 6 to a desired extent.

As shown in FIG. 6, particles 58 captured in sack 12 may permit onlypartial retraction of sack 12 into recovery sheath 6. Preferably,however, particles 58 captured in sack 12 cannot empty or escape intothe artery. Thereafter, recovery sheath 6, wire frame 8 and sack 12,with particles 58 captured in sack 12, are withdrawn from the patientalong with guide wire 4.

Referring now to FIGS. 7A and 7B, there is illustrated an alternativeembodiment of the present invention, illustrating tubular component 39attached to the external surface of portion 33 of containment collar 32,and further illustrating pull wire 34 coiled about guide wire 4 tocontain its lateral movement in the patient. The degree of coiling ispreferably within the range of coiling that retains pull wire 34 closelyadjacent guide wire 4, but not so great as to undesirably reducetorquability of the device. In this embodiment, containment collar 32has the same portion 33, and lumen 36 of containment collar 32 remainscontinuous with lumen 37 of portion 33 to permit containment collar 32to be slidably advanced over guide wire 4. However, in this embodiment,portion 33 is firmly gripped about its exterior by tubular component 39as illustrated in FIGS. 7A and 7B, which tubular component 39 is in turnassociated with pull wire 34 to connect pull wire 34 to containmentcollar 32 through tubular component 39. Again, pull wire 34 may beconnected to tubular component 39 by any of various means including, butnot limited to, welding, brazing, soldering or integral forming, as forexample, where tubular component 39 is formed by coiling pull wire 34 asdescribed above. In this embodiment, lumen 40 of tubular component 39 isof sufficient diameter to accept the external diameter of portion 33 ina preferably frictional fit of sufficient grasp so as to enableendovascular device 2 to be delivered into and removed from a patientwithout tubular component 39 separating from containment collar 32.

The axial length of portion 33 need only be sufficient to permit tubularcomponent 39 to grasp containment collar 32 sufficiently firmly so as toenable endovascular device 2 to be delivered into and removed from apatient without tubular component 39 separating from containment collar32, but it may be longer. A length of approximately 12 centimeters ofthe length of portion 33 ensures that tubular component 39 remainswithin and does not exit the distal end of the lumen of guide catheter42 common to most all endovascular procedures when wire frame 8 and sack12 are properly positioned past the lesion. In other words, when wireframe 8 and sack 12 are positioned past a lesion, a length of at least12 centimeters for portion 33 ensures that tubular component 39 issufficiently distanced from wire frame 8 and sack 12 that tubularcomponent 39 will remain within the confines of guide catheter 42.Keeping tubular component 39 within the confines of guide catheter 42 isdesirable, as it is one less item that can contact the vessel walls andundesirably dislodge particles.

Referring now to FIG. 8, there is illustrated yet another embodiment ofthe present invention wherein pull wire 34 includes one or more coiledsections 60, illustrated in phantom. Each coiled section 60 ispreferably displaced at least a distance 61 proximally of tubularcomponent 39 such that when endovascular device 2 is deployed in a bodycanal or vessel, coiled section 60 remains within the confines of aguide catheter 62. In this embodiment, the torquability of endovasculardevice 2 is not compromised. Also, this embodiment ensures that nocoiling will be present in distance 61 between guide catheter 62 and theprocedure site, which is preferred as such coiling could irritate vesselwalls or undesirably dislodge particles. Although two coiled sections 60are illustrated in FIG. 8, additional coiled sections 60 may bepositioned along the length of guide wire 4.

Referring now to FIGS. 9A and 9B, a side view and a rotated side view,respectively, of an object capture device in accordance with anotherembodiment of the present invention are illustrated. In this embodiment,wire frame 8 and sack 12 are connected to a tightly wound but flexiblecoil of wire 66, or spring, which defines a lumen 67 therethrough.Preferably, coil of wire 66 is helically wound in the form of acylinder. The proximal end of control arms 26 are connected to coil ofwire 66 at a junction 68 adjacent one end of coil of wire 66, and apex20 of sack 12 is connected to coil of wire 66 adjacent the other end ofcoil of wire 66. The proximal ends of control arms 26 can be connectedto coil of wire 66 via junction 68 in the same manner as control arms 26are connected to guide wire 4 via junction 10 in FIG. 2. Coil of wire 66is configured to be firm axially, but pliable laterally. This enablescoil of wire 66 to bend and follow the path of guide wire 4 in a bodycanal or vessel while avoiding axial elongation of coil of wire 66 whichmay cause tension to be applied to wire frame 8 and/or sack 12 betweenjunction 68 and apex 20 of sack 12. A distal stop 70 and a proximal stop72 are connected in spaced relation to guide wire 4. Stops 70 and 72 areeach formed from a solder joint of biocompatible material or a weld.

In use, guide wire 4 is received in lumen 67 and coil of wire 66 isreceived on guide wire 4 between stops 70 and 72 which prevent coil ofwire 66, and hence, wire frame 8 and sack 12, from moving on guide wire4 distally of distal stop 70 and proximally of proximal stop 72. Morespecifically, stops 70 and 72 have a diameter larger than the insidediameter of coil of wire 66 thereby preventing slidable movement of coilof wire 66 axially along guide wire 4, distally of distal stop 70 orproximally of proximal stop 72.

Starting with wire frame 8 and sack 12 received in containment collar 32and with coil of wire 66 received on guide wire 4 between stops 70 and72, pliable tip 22 is inserted percutaneously into the patient throughthe proximal end of guide catheter 42 previously inserted in accessopening 41. Guide wire 4 is manipulated to advance pliable tip 22, coilof wire 66, containment collar 32 and pull wire 34 through guidecatheter 42 until pliable tip 22 approaches the distal end of guidecatheter 42. Next, guide wire 4 is further advanced beyond the distalend of guide catheter 42, guided by pliable tip 22, until containmentcollar 32 is positioned at a desired position in a body canal or vessel.Because coil of wire 66 is flexible laterally, it is able to conform totwists and bends taken by guide wire 4 during manipulation to advancecontainment collar 32 to the desired position.

Once containment collar 32 is at the desired position, a portion of pullwire 34, or handle 38, outside the patient's body is pulled proximallywhile, at the same time, a portion of guide wire 4 outside the patient'sbody is held stationary. Pulling pull wire 34 or handle 38 proximallycauses containment collar 32 to be retracted or withdrawn from over wireframe 8 and sack 12 whereupon wire frame 8 deploys and holds mouth 14 ofsack 12 snugly against the wall of a body canal or vessel. Thereafter,pull wire 34 and containment collar 32 are pulled proximally throughguide catheter 42 while guide wire 4 remains stationary untilcontainment collar 32 is completely removed from guide wire 4.

Alternatively, containment collar 32 is omitted and replaced by adeployment catheter 43 (shown in phantom in FIGS. 9A and 9B) which has alumen 44 of sufficient inside diameter to receive guide wire 4 and coilof wire 66, with wire frame 8 and sack 12 in their collapsed state,therein. Starting with coil of wire 66 received on guide wire 4 betweenstops 70 and 72, with wire frame 8 and sack 12 received in theircollapsed state in lumen 44 adjacent the distal end of deploymentcatheter 43 received on guide wire 4, and with pliable tip 22 extendingfrom the distal end of the deployment catheter 43, pliable tip 22 andthe distal end of deployment catheter 43 are inserted percutaneouslyinto the patient through guide catheter 42 previously inserted in accessopening 41. Deployment catheter 43 and guide wire 4 are manipulated sothat the distal end of deployment catheter 43 and pliable tip 22 advancethrough guide catheter 42 until pliable tip 22 approaches the distal endof guide catheter 42. Next, the distal end of deployment catheter 43 andguide wire 4 are further advanced beyond guide catheter 42, guided bypliable tip 22, until coil of wire 66 is positioned at a desiredposition in a body canal or vessel.

Once coil of wire 66 is at the desired position, a portion of deploymentcatheter 43 outside the patient's body is pulled proximally while, atthe same time, a portion of guide wire 4 outside the patient's body isheld stationary. Pulling deployment catheter 43 in this manner causesdeployment catheter 43 to be retracted or withdrawn from over wire frame8 and sack 12 whereupon wire frame 8 deploys and holds mouth 14 of sack12 snugly against the wall of a body canal or vessel. Thereafter,deployment catheter 43 is pulled proximally through guide catheter 42,while guide wire 4 remains stationary, until deployment catheter 43 iscompletely removed from guide wire 4.

Next, an over-the-wire or monorail device or component can be receivedon guide wire 4 and delivered through guide catheter 42 to a positionproximal of proximal stop 72 to perform a procedure that the particularover-the-wire or monorail device is configured to perform. Once theprocedure has been performed, the over-the-wire or monorail device iswithdrawn from guide wire 4 through guide catheter 42.

Thereafter, recovery sheath 6, of the type shown in FIG. 1D, ispositioned over guide wire 4 and is advanced distally thereon throughguide catheter 42 to contact wire frame 8. Further advancement ofrecovery sheath 6 distally on guide wire 4 causes all or a portion ofwire frame 8 and all or a portion of sack 12 to be retracted intorecovery sheath 6 to a desired extent. Thereafter, recovery sheath 6,wire frame 8 and sack 12 with any particles 58 captured in sack 12 arewithdrawn from the patient along with guide wire 4.

Guide wire 4 and lumen 67 and are configured to enable rotation of guidewire 4 in coil of wire 66. Distal and proximal stops 70 and 72 arespaced so that coil of wire 66 can reside between them. If the spacingbetween distal and proximal stops 70 and 72 is slightly greater than thelength of the coil of wire 66, guide wire 4 can only rotate in lumen 67.Such ability to rotate is important to prevent loading of the guide wire4 to reduce its torquability. If spacing between distal and proximalstops 70 and 72 is greater than the length of coil of wire 66, coil ofwire 66 can rotate in lumen 67 and can move linearly along the guidewire 4. Thus, when deployed, wire frame 8 does not rub the wall of thebody canal or vessel in response to longitudinal movement of guide wire4 that does not move distal stop 70 or proximal stop 72 into contactwith coil of wire 66.

With continuing reference to FIGS. 9 a and 9 b, in another embodiment,proximal stop 72 is omitted, wire frame 8 and sack 12 are connected tocoil of wire 66, wire frame 8 and sack 12 are received in containmentcollar 32, guide wire 4 is received in lumen 67, and coil of wire 66 isreceived on guide wire 4 between distal stop 70 and the distal end ofdeployment catheter 43 received on guide wire 4 proximally of distalstop 70. Lumen 44 has a sufficient inside diameter to slidably receiveguide wire 4 therein. However, in this embodiment, lumen 44 issufficiently small whereupon the distal end of deployment catheter 43abuts an end of coil of wire 66 when deployment catheter 43 and coil ofwire 66 are received on guide wire 4.

In use, pliable tip 22 and containment collar 32, with the distal end ofdeployment catheter 43 abutting the proximal end of coil of wire 66having guide wire 4 received in lumen 67, are inserted percutaneouslyinto the patient through a lumen of guide catheter 42 which has beenpreviously inserted in access opening 41. Guide wire 4 and deploymentcatheter 43 are manipulated to advance pliable tip 22, containmentcollar 32 and coil of wire 66 through guide catheter 42 until pliabletip 22 approaches the distal end of guide catheter 42. Morespecifically, guide wire 4 and deployment catheter 43 are urged distallywhile, at the same time, a portion of guide catheter 42 outside of thepatient's body is held stationary whereupon pliable tip 22, containmentcollar 32, coil of wire 66, deployment catheter 43 and guide wire 4advance through guide catheter 42. In this embodiment, pull wire 34extends through the lumen of guide catheter 42 and, more particularly,pull wire 34 is disposed between the interior surface of guide catheter42 and the exterior surface of deployment catheter 43. Next, pliable tip22 and containment collar 32 are urged beyond the distal end of guidecatheter 42, guided by pliable tip 22, until coil of wire 66 andcontainment collar 32 are positioned at a desired position in a bodycanal or vessel.

Alternatively, pliable tip 22 of guide wire 4 is first insertedpercutaneously into the patient through a lumen of guide catheter 42which has been previously inserted in access opening 41. Guide wire 4 ismanipulated to advance pliable tip 22 to the distal end of the guidecatheter 42. Pliable tip 22 is urged beyond the distal end of guidecatheter 42 until distal stop 70 is positioned at a desired position inthe body canal or vessel. Thereafter, deployment catheter 43 and coil ofwire 66, with wire frame 8 and sack 12 received in containment collar32, are received on guide wire 4 with the proximal end of containmentcollar 32 enclosing the distal end of deployment catheter 43 as it abutsthe proximal end of coil of wire 66. Next, deployment catheter 43 ismanipulated through guide catheter 42 along guide wire 4, while guidewire 4 and guide catheter 42 are held stationary, to advance coil ofwire 66 and containment collar 32 over guide wire 4 toward distal stop70 and to a desired position in the body canal or vessel. Pull wire 34extends through the lumen of guide catheter 42 and, more particularly,pull wire 34 is disposed between the interior surface of guide catheter42 and the exterior surface of deployment catheter 43.

Once coil of wire 66 and containment collar 32 are at the desiredposition in the body canal or vessel, a portion of pull wire 34, orhandle 38, outside the patient's body is pulled proximally while, at thesame time, portions of guide catheter 42 and deployment catheter 43outside the patient's body are held stationary. In response to pullingpull wire 34 or handle 38 proximally, tubular component 39 andcontainment collar 32 advance proximally over deployment catheter 43whereupon wire frame 8 deploys and holds mouth 14 of sack 12 snuglyagainst the wall of the body canal or vessel. Proximal advancement oftubular component 39 and containment collar 32 over deployment catheter43 continues until they are received in guide catheter 42. Thereafter,deployment catheter 43, tubular component 39 and containment collar 32are removed from guide catheter 42 and guide wire 4.

Next, an over-the-wire or monorail device or component can be receivedon guide wire 4 and delivered through guide catheter 42 to a positionproximal of wire frame 8 and sack 12 to perform the procedure theover-the-wire or monorail device or component is configured to perform.Once the procedure has been performed, the over-the-wire or monoraildevice or component is withdrawn from guide catheter 42 and guide wire4.

Thereafter, recovery sheath 6 is positioned over guide wire 4 andadvanced distally thereon through guide catheter 42 to contact wireframe 8. Further advancement of recovery sheath 6 distally on guide wire4 causes all or a portion of wire frame 8 and/or all or a portion ofsack 12 to be retracted into recovery sheath 6 to a desired extent.Thereafter, recovery sheath 6, wire frame 8 and sack 12, and anyparticles 58 captured in sack 12, are withdrawn from the patient alongwith guide wire 4.

Recovery sheath 6 in FIG. 1D is shown as having an elongated tubularform. However, a retrieval catheter assembly 100 of the type shown inFIGS. 10A–10C can be utilized to retrieve wire frame 8 and sack 12.Retrieval catheter assembly 100 includes in coaxial arrangement havingan inner tube 102 and an outer tube 104. Inner tube 102 includes a lumen106 configured to slidably receive guide wire 4 therein, while outertube 104 includes a lumen 108 configured to slidably receive inner tube102 therein.

Outer tube 104 is connected at its proximal end to a fitting 110.Fitting 110 has a lumen 111 configured to slidably receive inner tube102 therethrough. A Y-connector 112 is slidably received on inner tube102 and guide wire 4 on a side of fitting 110 opposite wire frame 8 andsack 12. A fitting 114 is coupled to an end of inner tube 102 oppositewire frame 8 and sack 12. Fitting 114 includes a lumen 115 configured toslidably receive guide wire 4 therethrough when fitting 114 is connectedto inner tube 102. Fittings 110 and 114 are configured to be mated toopposite ends of Y-connector 112. More specifically, fittings 110 and114 include female threads (not shown) configured to be threadably matedwith male threads (not shown) formed on opposite ends of Y-connector112. In one embodiment, Y-connector 112 includes a male threaded sideport 118 having a female threaded cap 116 threadably mated thereon.

Y-connector 112 is configured in a manner known in the art to enableguide wire 4 and inner tube 102 to be received therethrough whileavoiding the undesired seepage of fluid from a body canal or vessel vialumen 106 of inner tube 102 when wire frame 8 and sack 12 are deployedin a body canal or vessel of a patient. Cap 116 can be removed from sideport 118 so that a syringe can be received in side port 118 forintroducing fluids into the body canal or vessel of the patient vialumen 108 of outer tube 104 when inner tube 102 is loosely receivedtherein. Preferably, however, inner tube 102 and outer tube 104 fitsnugly and slidably together in a manner that avoids the effectivepassage of fluid in lumen 108. Similarly, guide wire 4 and inner tube102 fit snugly and slidably together in a manner that avoids theeffective passage of fluid in lumen 106.

At an appropriate time, with fittings 110 and 114 coupled to Y-connector112, retrieval catheter assembly 100 is positioned over guide wire 4 andadvanced distally thereon, preferably through guide catheter 42, tocontact wire frame 8. Preferably, during advancement of inner tube 102on guide wire 4, the distal end of inner tube 102 extends distally outof lumen 108 a short distance as shown in FIG. 10A. Because of the snugand slidable fit between guide wire 4 and inner tube 102 and since thedistal end of inner tube 102 extends distally out of lumen 108 whenretrieval catheter assembly 100 is slidably advanced on guide wire 4,inner tube 102 and outer tube 104 accurately track the path of guidewire 4 in the body canal or vessel of the patient in a manner thatavoids the distal end of inner tube 102 or the distal end of outer tube104 from contacting a protrusion or a stent deployed in a body canal orvessel of the patient, or from contacting the intima of the body canalor vessel where guide wire 4 makes relatively sharp turns therein.

When the distal end of inner tube 102 is contacting or is closelyadjacent the connection of wire frame 8 to guide wire 4, fitting 114 isuncoupled from Y-connector 112. Thereafter, fitting 114 is pulledproximally whereupon inner tube 102 moves proximally on guide wire 4 andis retracted into lumen 108 of outer tube 104, and Y-connector 112 isadvanced distally on guide wire 4 whereupon the distal end of outer tube104 advances over wire frame 8 and, if desired, over sack 12 to adesired extent. Preferably, Y-connector 112 is advanced sufficientlydistally that all of wire frame 8 and all or a portion of sack 12 arereceived in the space in lumen 108 between the distal end of inner tube102 and the distal end of outer tube 104. Alternatively, withY-connector 112 held stationary, guide wire 4 can be pulled proximallyso that all of wire frame 8 and all or a portion of sack 12 areretracted into lumen 108 in the space between the distal end of innertube 102 and the distal end of outer tube 104. Thereafter, retrievalcatheter assembly 100, and more particularly, inner tube 102 and outertube 104 with wire frame 8 and sack 12 partially or wholly received inlumen 108, are withdrawn from the patient along with guide wire 4.

Referring now to FIGS. 11A and 11B, a perspective view and a side view,respectively, of another embodiment of a wire frame 134 for use with theobject capture device of the present invention is illustrated. In thisembodiment, sack 12 is connected to wire frame 134 which includes an arm136 connected at one end to a junction 138 and at another end to a loop140 to which mouth 14 of sack 12 is connected. Arm 136 and loop 140 areformed from a shape-memory-effect alloy which can be received in acollapsed state or structure within containment collar 32, recoverysheath 6 or outer tube 104 of retrieval catheter assembly 100 in thesame manner as half frames 24 and control arms 26 of wire frame 8. Inaddition, arm 136 and loop 140 can be deployed outside of containmentcollar 32 in its expanded or deployed state or structure shown in FIGS.11A and 11B. Arm 136 extends distally from its connection to junction138 and radially away from guide wire 4. Guide wire 4 extends throughmouth 14, loop 140 and apex 20 of sack 12. Apex 20 and junction 138 canbe coupled to guide wire 4. Alternatively, apex 20 and junction 138 canbe slidably received on guide wire 4 between a pair of stops, e.g.,distal stop 70 and proximal stop 72, of the type shown in FIGS. 9A and9B.

As can be seen from the foregoing, endovascular device 2 of the presentinvention provides several important advantages over other systems.These include, but are not limited to, the device's ability to enableemboli shed during angioplasty and stenting procedures to be safelycaptured and removed. Its design facilitates scaling for use in variousdiameter vessels. The shape-memory-effect alloy permits wire frame 8 toclosely conform with the intima of a blood vessel while avoiding traumato the blood vessel. Pliable tip 22 and/or the extension of the distalend of guide wire 4 the distance 18 beyond bottom 16 of sack 12 permitsmanipulation of endovascular device 2 through tortuous vascularconfigurations, and containment collar 32 permitting such manipulationwithout the undesirable reduction of torquability associated withpresently available systems. Guide wire 4 enables delivery of otherdevices to the lesion site. Sack 12 connected to wire frame 8 acts toform a basket that can be manipulated to a position outside containmentcollar 32 where the mouth of the basket is open and a position insidecontainment collar 32 where the mouth of the basket is closed, and viceversa. The material used to construct sack 12 can be porous ornon-porous. When sack 12 is made of a porous material, it acts as afilter that allows blood to flow and captures particles of a sizegreater than the pores. When sack 12 is made of a non-porous material,it occludes blood flow and movement of solid particles thereby.

In an alternative embodiment, a suction device can be used to removeparticles trapped by sack 12 made of non-porous material.

The present invention may be employed to capture objects in body organs,cavities, canals or other structures within the body, so as tofacilitate the entrapment within and/or removal of the object from thebody. The apparatus of the present invention may be positioned andemployed to capture the object using fluoroscopic visualization ingeneral and angiography with dye injection in particular, among otherpositioning methods and devices. The present invention may be utilizedin any medical procedure where it is desirable to entrap particles inblood or other vessels, but is particularly advantageous for use withendovascular procedures including, but not limited to, mechanical andlaser thrombectomy, angioplasty and stenting operations to dilateoccluded vessels and yet minimize embolic events.

The invention has been described with reference to the preferredembodiments. Obvious modifications and alterations will occur to othersupon reading and understanding the preceding detailed description. Forexample, while endovascular device 2 has been described in connectionwith containment collar 32 being utilized with wire frame 8 and sack 12,it is to be appreciated that containment collar 32 can be utilized todeploy other configurations of collapsible or resilient frames having asack, basket or filter attached thereto. Non-limiting examples of thetypes of collapsible or resilient frames and filters that can bedeployed using containment collar 32 include those illustrated in U.S.Pat. No. 6,129,739 to Khosravi; U.S. Pat. No. 6,152,946 to Broome etal.; U.S. Pat. No. 6,179,861 to Khosravi et al.; and InternationalPublication Nos. WO 96/01591 and WO 99/23976, the disclosures of whichare incorporated herein by reference. It is intended that the inventionbe construed as including all such modifications and alterations insofaras they come within the scope of the appended claims or the equivalentsthereof.

1. An apparatus for removing a solid object from a body canal or vessel,the apparatus comprising: a wire frame; a coil of wire having two endsand helically wound in the form of a cylinder defining a lumentherethrough, said coil of wire being capable of rotation or linearmovement when positioned on a guide wire, said coil of wire furtherconfigured to be firm axially, but pliable laterally, such that saidcoil of wire can conform to twists and bends taken by said guide wireduring manipulation and advancement of said guide wire; a sack affixedto said wire frame, said sack having an apex, wherein said apex of saidsack is connected to one of said ends of said coil of wire; control armsattached to said wire frame and having proximal ends connected near theother end of said coil of wire via a junction; whereby said coil of wirecan bend and follow a path of said guide wire while avoiding axialelongation of said coil of wire.
 2. The apparatus of claim 1, whereinsaid guide wire includes a proximal stop and a distal stop in spacedrelation on said guide wire; said coil of wire is received on said guidewire between said proximal stop and said distal stop; and each said stopis configured to avoid the slidable passage of said coil of wirethereby.
 3. The apparatus of claim 1, further comprising a containmentcollar configured to slidably receive the guide wire therethrough and toreceive at least part of the frame therein.
 4. The apparatus of claim 3,further comprising a pull wire connected to said containment collar.